La Jolla oncologist pleads guilty to importing unapproved drug

The U.S. Attorney's office announced today (Jan. 23) that La Jolla oncologist Dr. Joel I. Bernstein pleaded guilty to introducing an unapproved drug into interstate commerce. He also pleaded guilty to health care fraud. The drug was Turkey's Mabthera, which has the same active ingredient as Rituxan, which is used to treat non-Hodgkin's Lymphoma and other cancers. Rituxan was originally developed in San Diego by IDEC Pharmaceuticals, now part of Biogen Idec of Cambridge, Massachusetts. Bernstein was released pending sentencing, scheduled for April 16 at 1:30 p.m. before U.S. Magistrate Judge Bernard Skomal. Bernstein's medical practice also pleaded guilty to the offenses.

Comments

Mabthera appears to be the same drug as Rituxan and is made by the same company. It appears that the drug was branded Mabthera in Europe for pricing reasons, so Americans won't ask why Rituxan costs more than Mabthera. I searched Mabthera on the internet and many Americans are buying the drug because it costs much less than Rituxan. I'm not convinced Bernstein is a crook. They should have indicted the drug company. Most drug companies have more salesmen on the payroll than researchers, and salesmen are paid more.

Burwell: You have done your homework on this one, as always. If Mabthera is the same as Rituxan, but sold at a lower price in Europe, then the U.S. may be using its law enforcement system to prop up Rituxan's price domestically, thus, presumably, protecting the manufacturer. However, the U.S. government says Mabthera is not approved by the Food & Drug Administration. According to the U.S. Attorney's office, Bernstein's employees purchased $3.4 million of foreign cancer drugs, knowing they were not FDA-approved. They were purchased for a significantly lower price than the U.S. product, but claims were submitted to Medicare for the higher price, says the government. Best, Don Bauder

The doctor may have been trying to help his patients. I take Rituxan for Rheumatoid Arthritis, 2 infusions each treatment, twice a year. This wouldn't be possible without insurance as the yearly cost is $58,000. I believe the dosage for RA is tiny compared with what is required for cancer. I wonder what Europeans pay for Mabthera.

gibbs: The FDA says there is an alarming trend of use of foreign drugs, particularly injectable chemotherapy drugs, that have not been vetted by the agency. The FDA says it constitutes "an epidemic of unapproved and counterfeit drugs." Laura Duffy, U.S. Attorney in San Diego, says, "This isn't just about the greed of one doctor, but about the welfare of many patients." What we don't know is whether Mabthera is an exact copy, or close to exact copy, of Rituxan. Best, Don Bauder

Don--
Not defending this physician (billing as Rituxan sounds like fraud), but I don't think the FDA "bureaucrats" can approve a drug without a request/application from the manufacturer (with lots of data as part of the submission). Yes approval of applications can be very slow, but I'll bet you a beer that there's no application pending for Mabthera. To what extend Mexican & Canadian clinics are due to slow FDA approval of requests v. pharmaceutical companies not wanting or applying for approval in the US is an empirical question.

As his patient, my concern is his failure to inform, discuss and obtain consent from those receiving the drug without FDA approval. The active ingredient was listed on the label. That's great but without FDA approval there is a potential risk that the drug was not stored or transported at the appropriate temperature range for example. I want complete confidence that my physician and his staff have my best interests at heart and now sadly this incident has damaged my trust. Additionally, I assume the oncology nurse participated in ordering the chemo agents. If so, and she knowingly participated in this scheme, then the State Board of Registered Nurses should conduct an investigation too. Thank you for listening.

Jamesbondberger: You make the same points that the government makes. San Diego US Attorney Laura Duffy says, "In a worst-case scenario, chemotherapy drugs that have not been approved by the FDA may be fake, ineffective, unsafe, and dangerous."Best, Don Bauder

Some of you are either very naive or related to this crook. The issue here is not how the US FDA regulates drugs, it's that this guy lives in the US, works in the US and ... defrauded the US with one of the oldest tricks in the book used with everything from caviar to auto parts: buy the stuff on the black market for cheap then claim its the "real stuff" bought for the official price and pocket the difference. No, he didn't save his patients any money and thus didn't do them a favor. He did it for his own gain. Yeah, maybe the drug is the same but...did he actually do his own efficacy tests for the doses he bought? What were the expiration dates? Did the stuff first spend a year in an overheated wearhouse? Would you want this mystery-background stuff injected into your body?

My wife was treated by this guy, thankfully without chemo although it we discussed it with him as an option. I sure don't remember his saying anything about getting a drug rebate.
So ultimately he's just caused all our future medical insurance payments to rise due to fraud. Thanks Ex-doc!

Whatever Dr. Bernstein's motive, he was clearly in violation of interstate commerce law. Those laws are clear about purchases of large quantities of foreign-made drugs for purposes of resale or distribution. I can't imagine why he continued after being warned.

I know lots of individuals who avoid the Medicare donut hole by buying generic drugs from registered Canadian pharmacies, which provide European-produced drugs that can be had for much better prices than their American-produced counterparts (the Lipitor generic is one example). Some Big Pharma companies go through hoops to bar the generic versions of their patented drugs in the USA, even though they produce and market the same drugs generically in Europe.

Our government has a truce with seniors and other patients on this issue: they turn a blind eye to the clearly labeled packages as they come through customs checks. As long as the quantity is obviously for personal use only, obtained by legit prescriptions by an individual's doctor, from registered Canadian suppliers, no problem. This has been the status quo for decades. In some towns near the Canadian border, senior groups participate in "pill runs" on tour busses that cross the Canadian border to pick up prescriptions.

Dr. Bernstein is respected and a great doc, but the laws are necessary, because not everyone who will do what Bernstein did is trustworthy, respected, or a great doc.

This is all very hard to understand. It is extraordinarily difficult to get admitted to medical school. The candidates have to set their sights on the goal of an MD when they are high school frosh, and get stellar grades all the way through high school and college. They also have to provide evidence they are of good character, are well rounded (meaning some sports and/or activities), and get recommendations from several sources. After going to all that jumping-through-the-hoop and then the rigors of med school and usually four years of residency, they are set for life. Yes, many are in debt to the tune of a quarter million, but the jobs they get pay very well. You would think after all that self-sacrifice and self-discipline they would never dream of violating either trust or laws. And yet too many MDs get greedy and try to become billionaires from their practices, and that involves lack of ethics or just pure criminal activity. What a come-down for such a high achieving person and a tarnished record.

Visduh: Another angle: doctors are notoriously bad investors. They fall for some of the most naked scams. People in the profession try to explain it this way: doctors are accustomed to believing patients describing their symptoms -- thus, they fall for con artists. I can't accept that explanation. Best, Don Bauder